MedTech Europe has published its position paper on the proposed Data Act
Posted on 01.12.2022
MedTech Europe has published a position paper on the proposed Data Act. Connected medical technologies are impacted by this regulation as they will be required to make data generated using a product or service accessible to the user or third parties specified by the user.
In its paper, MedTech Europe calls on policymakers to recognise the complexity of the healthcare sector as the requirements would bring new challenges, especially regarding the interaction with existing legislation. The Data Act should not oblige the manufacturers of connected medical technologies to make data available outside the confines of the secure and well-regulated framework of MDR, IVDR and GDPR. Furthermore, there is a need for more clarity on the scope and central definitions of the legislation as well as increased safeguards for the protection of IP rights and trade secrets. The complete position paper can be accessed here.
For more information, please contact Verena Thaler, Manager Digital Health.